Tracheal and airway stenosis can be caused by a number of reasons to include tissue reaction from a tracheostomy or endotracheal intubation. Tracheal stenosis can also be caused by collagen vascular diseases and malignant conditions of the airways. In some cases, a short segment stenosis can be treated with surgical resection. Complex stenosis, long stenosis, and stenosis occurring at the very proximal portion of the trachea are not effectively treatable with surgical resection, and therefore require treatment via a rigid or flexible bronchoscope.
Bronchoscopic therapies include laser excision, balloon dilation, and rigid bronchoscopic dilation, injection of corticosteroids, topical mitomycin-C and silicone stent placement. Silicone stents are effective at maintaining airway patency; however, one of the known complications is stent migration. Stent migration can be particularly problematic when a stent is placed in the proximal subglottic space.
One known solution to prevent tracheal stent migration is the incorporation of a plurality of protrusions or studs on the outer surface of the stent. Over a period of time, these studs/protrusions will seat into the tracheal wall to help prevent migration, however, a tracheal stent is very prone to migration prior to seating of the studs. Further, inflammation of the trachea may be exacerbated by migration of the stent in which the studs may cause greater frictional contact with the tracheal wall as the stent migrates.
Therefore, there is a need to provide a safe and effective means for securing tracheal airway stents in the proximal airway or tracheal space without migration. Further, there is a need to anchor the stents in a non-obtrusive manner that does not further irritate the tracheal wall.